Drugplain

NightTime Cold and Flu 325 mg/1

Acetaminophen,Dextromethorphan,Doxylamine · CAPSULE, LIQUID FILLED · Velocity Pharma

No Recall History
Plain English

Nighttime Cold And Flu is an over-the-counter liquid-filled capsule containing acetaminophen to reduce fever and pain, dextromethorphan to suppress cough, and doxylamine to help you sleep through cold and flu symptoms. Take it by mouth as directed on the package label.

Key Facts

Brand Name
NightTime Cold and Flu
Generic Name
Acetaminophen,Dextromethorphan,Doxylamine
NDC Code (Product)
76168-056
Manufacturer
Velocity Pharma
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
part341
Marketing Start
05/01/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use22,388 reports
fatigue20,433 reports
drug ineffective18,157 reports
pain18,106 reports
nausea17,626 reports
headache16,714 reports
toxicity to various agents15,544 reports
dyspnoea14,577 reports
arthralgia14,308 reports
pyrexia14,269 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these common cold/flu symptoms minor aches and pains headache sore throat fever runny nose and sneezing cough due to minor throat and bronchial irritation

Dosage & Administration

Directions do not take more than directed (see Overdose warning) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL = milliliter keep dosing cup with product adults and children 12 years and over: 30 mL every 6 hours children under 12 years of age: do not use when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks everyday while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist Ask a doctor before use if you have liver disease glaucoma cough that occur

Frequently Asked Questions

What is NightTime Cold and Flu used for?

Nighttime Cold And Flu is an over-the-counter liquid-filled capsule containing acetaminophen to reduce fever and pain, dextromethorphan to suppress cough, and doxylamine to help you sleep through cold and flu symptoms. Take it by mouth as directed on the package label.

Is NightTime Cold and Flu a controlled substance?

NightTime Cold and Flu is not classified as a controlled substance by the DEA.

What is the generic name for NightTime Cold and Flu?

The generic name for NightTime Cold and Flu is Acetaminophen,Dextromethorphan,Doxylamine. There are no other listed brand versions of Acetaminophen,Dextromethorphan,Doxylamine.

What is the NDC code for NightTime Cold and Flu 325 mg/1?

The NDC (National Drug Code) for NightTime Cold and Flu 325 mg/1 is 76168-056, listed by Velocity Pharma.

Product NDC

76168-056

Package NDC

76168-056-02

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)